| CTRI Number |
CTRI/2026/01/100834 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to see how Phalatrikadi Yoga and Virechana karma help in managing abnormal blood lipid level. |
|
Scientific Title of Study
|
An Open-Label Randomized Controlled Clinical Study to Evaluate the Efficacy of Phalatrikadi Yoga and Virechana Karma in the Management of Medoroga w.s.r. to Dyslipidemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Vijay Chaudhary |
| Designation |
Principal cum Dean |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP |
| Address |
Room no317 hospital building Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP
Room no317 hospital building Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vijay Chaudhary |
| Designation |
Principal cum Dean |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP |
| Address |
Room no317 hospital building Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP
Room no317 hospital building Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Verma |
| Designation |
MD Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP |
| Address |
Room no317 hospital building Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP
Room no317 hospital building Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09815439814 |
| Fax |
|
| Email |
anjaliverma55555@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic pharmacy paprola, Dist. kangra, Herbal Garden and Herbarium, Research Institute in ISM, Joginder Nagar, Dist. mandi, H.p |
|
|
Primary Sponsor
|
| Name |
RGGPG ayurvedic college and hospital paprola |
| Address |
Room no317 hospital building Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali Verma |
RGGPG Ayurvedic College and Hospital Paprola HP |
Room no317 hospital building Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP
Kangra
HIMACHAL PRADESH |
09815439814
anjaliverma55555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe (Human) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charaka Chapter 21 shloka 12, Procedure details: Purvakarma Deepan Pachan It will be performed by the administration of Trikatu Churna 3 g twice daily before food with lukewarm water till the symptoms of appropriate Agni Deepana were attained by Trikatu Churna. Snehpana Murchit Goghrita DOSE Snehpana Murchit Goghrita will be initiated from the dose of 40ml & will be continued for 3-7 days in increasing pattern depending upon Koshtha & Agni of the individual till the appearance of Samyak Snehan Lakshana. Sarvang Abhyanga and Swedana After appearance of Samyak Snehan Lakshana the next 3 days and on the day of Pradhanakarma i.e. the fourth day Sarvanga Abhyanga with Murchit Tila Taila will be performed followed by Sarvanga Swedana. On the previous day of Pradhankarma individual will be asked to take Laghu Snigdha Drava Ushna Ahara Mamsa Rasa Diet should be such that it should not increase kapha as it may cause Vaman Acharya Sushrut advised light diet and Phalamal Ras (Su.Ch.31/20) Pradhankarma Virechana Dravya Trivrit Churna Trikatu Churna and Tripahala Kasahaya Form used Powder form Dose After the Koshtha assessment of the individual Virechana Karma will be carried out as per Ayurvedic text Minimum 6gm and maximum 24gm Anupana Ushana Jala
Paschatkarma
Samsarjana Krama: Samsarjana Krama will be advised for 4, 8, 12 Annakala upto 3 (4 Annakala), 5 (8 Annakala), 7 (12 Annakala) days depending upon Hina, Madhya, Pravara Shudhi respectively.
Pariharya (Behavioural & Dietary restrictions)
duration-21days.)
(1) Medicine Name: Phalatrikadi Yoga, Reference: Yog Ratnakar Utaradha shloka 5, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 12 Weeks | | 2 | Comparator Arm (Non Ayurveda) | | - | Rosuvastatin | Tab. Rosuvastatin 10 mg 1OD
Duration- 15 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who present with sign and symptoms of Medoroga w.s.r to Dyslipidemia as described in classical text.
2. Patients between the age group of 25-70 year of either gender will be selected for the study.
3. Serum lipid profile :
Serum Cholesterol - 200 to 300 mg/dl
Serum Triglycerides - 150 to 350 mg/dl
Serum LDL - 100 to 200 mg/dl
Serum VLDL - 30 to 100 mg/dl
Serum HDL - 20 to 40 mg/dl
4. Volunteers fit for Virechana Karma.
5. Patients willing to participate in the trial.
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing for the trial.
2. Patients who have completed participation in any other clinical trial during the last three months.
3. Patient having illness like Thyroid Dysfunction, Type II Diabetes Mellitus, Carcinoma, Renal and Hepatic disorders.
4. Patient having past history of Myocardial infarction, Unstable Angina and Congestive Cardiac Failure and Cerebrovascular Accident.
5. Patients Below the age of 30 yrs and above the age of 70 yrs.
6. Pregnant females and lactating mother.
7. Any other condition which the principal investigator thinks may jeopardize the study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To evaluate the effect of Phalatrikadi Yoga and Virechana Karma in the management of Medoroga w.s.r. to Dyslipidemia. |
3 and half months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare the efficacy of Pahalatrikadi Yoga and Virechana Karma with Rosuvastatin in the management of Medoroga w.s.r. to Dyslipidemia.
• To assess the clinical safety of Pahalatrikadi Yoga and Virechana Karma in patients of Medoroga w.s.r. to Dyslipidemia.
|
3 and half months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my research trial after completion as soon as possible. A total of 30 subjects will be studied in 2 groups. 15 study subjects will be managed with Virechana karma with Phalatrikadi yoga and 15 study subjects will be managed with Tab. Rosuvastatin 10mg 1 OD. the outcome will be analysed based on subjective parameters with appropriate statistical tools. |